› Forums › General Melanoma Community › PV 10 /Rose Bengal Compassionate Use begins
- This topic has 20 replies, 7 voices, and was last updated 10 years, 8 months ago by
JerryfromFauq.
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- November 30, 2010 at 9:33 pm
For those of you with non Visceral Melanoma, Provectus has started Compassionate Use of PV 10 here in Australia, it will be also available in the US soon. The previous Trials had success on a limited use basis which meant you could only have a number of injections on a certain amount of tumors only. This Compassionate use will be a lot more flexible. All the data from this will help set up the Protocol for Phase 3 Trals. I found this email for enquiries, [email protected]
best wishes
James
For those of you with non Visceral Melanoma, Provectus has started Compassionate Use of PV 10 here in Australia, it will be also available in the US soon. The previous Trials had success on a limited use basis which meant you could only have a number of injections on a certain amount of tumors only. This Compassionate use will be a lot more flexible. All the data from this will help set up the Protocol for Phase 3 Trals. I found this email for enquiries, [email protected]
best wishes
James
- Replies
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- December 1, 2010 at 3:48 am
Hi James. I do appreciate this post. Thank you. I know PV10 was a treatment we were interested in. It seemed to have good results, and people posted often about it last year and possibly early this year, but boy when the trials close you just don't hear much. I am glad to know this is an option. So far Jerry is still just dealing with little intransits. I wonder if it will be available for Stage III??
thank you again,
Susan and Jerry
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- December 1, 2010 at 3:48 am
Hi James. I do appreciate this post. Thank you. I know PV10 was a treatment we were interested in. It seemed to have good results, and people posted often about it last year and possibly early this year, but boy when the trials close you just don't hear much. I am glad to know this is an option. So far Jerry is still just dealing with little intransits. I wonder if it will be available for Stage III??
thank you again,
Susan and Jerry
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- December 1, 2010 at 5:31 am
Some info on PV-10 from Dermatology Times (although it was written by a guy from Provectus, the drug maker)
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- December 1, 2010 at 5:31 am
Some info on PV-10 from Dermatology Times (although it was written by a guy from Provectus, the drug maker)
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- December 2, 2010 at 2:35 am
I have been researching melanoma drugs for the last six months and based on what I have found PV-10 looks to be one of the more promissing investigational new melanoma drugs currently being tested in FDA / TGA trials right now. Based on the published Phase 2 results it looks like PV-10 works as well or better than any of the other new melanoma drugs. Objective and Complete response results are better than the other new melanoma drugs and from what I have read the side effects are minimal to moderate. Provectus Pharmaceuticals currently has over 40 patients enrolled in the PV-10 compassionate use program and is in discussion with the FDA designing their Phase 3 trial. I would definately look into PV-10 as an option. http://www.pvct.com
Dennis
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- December 2, 2010 at 2:35 am
I have been researching melanoma drugs for the last six months and based on what I have found PV-10 looks to be one of the more promissing investigational new melanoma drugs currently being tested in FDA / TGA trials right now. Based on the published Phase 2 results it looks like PV-10 works as well or better than any of the other new melanoma drugs. Objective and Complete response results are better than the other new melanoma drugs and from what I have read the side effects are minimal to moderate. Provectus Pharmaceuticals currently has over 40 patients enrolled in the PV-10 compassionate use program and is in discussion with the FDA designing their Phase 3 trial. I would definately look into PV-10 as an option. http://www.pvct.com
Dennis
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- December 2, 2010 at 2:35 am
I have been researching melanoma drugs for the last six months and based on what I have found PV-10 looks to be one of the more promissing investigational new melanoma drugs currently being tested in FDA / TGA trials right now. Based on the published Phase 2 results it looks like PV-10 works as well or better than any of the other new melanoma drugs. Objective and Complete response results are better than the other new melanoma drugs and from what I have read the side effects are minimal to moderate. Provectus Pharmaceuticals currently has over 40 patients enrolled in the PV-10 compassionate use program and is in discussion with the FDA designing their Phase 3 trial. I would definately look into PV-10 as an option. http://www.pvct.com
Dennis
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- December 2, 2010 at 2:35 am
I have been researching melanoma drugs for the last six months and based on what I have found PV-10 looks to be one of the more promissing investigational new melanoma drugs currently being tested in FDA / TGA trials right now. Based on the published Phase 2 results it looks like PV-10 works as well or better than any of the other new melanoma drugs. Objective and Complete response results are better than the other new melanoma drugs and from what I have read the side effects are minimal to moderate. Provectus Pharmaceuticals currently has over 40 patients enrolled in the PV-10 compassionate use program and is in discussion with the FDA designing their Phase 3 trial. I would definately look into PV-10 as an option. http://www.pvct.com
Dennis
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- December 2, 2010 at 6:59 am
I would like to know if this and what treatments are available for people with auto immune disease…like rheumatoid arthritus. I never realized how many people with melanoma stage 4 cannot take Ipi or PLX 4032 or any of the other "promising" treatments because of their disease and are reduced to using only conventional chemotherapy….I am blessed to not have any autoimmune diseases…but many of my friends do…anyone know anything "new" out there for them?
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- December 6, 2010 at 2:05 pm
Hello Lynn.
I checked with Provectus Pharmaceuticals and asked them if patients with auto immune diseases…like rheumatoid arthritus could qualify for their PV-10 Phase 3 Trial or their Compassionate Use Program and this is the answer I received. I hope this helps. Have a great day!
Dennis, I’ve checked with Eric Wachter who runs our clinical trial programs. He says “This is not a current exclusion criterion.” So, the answer to your question is “yes.”
Please let me know of anything else.
Thanks!
Pete
Peter R. Culpepper, CFO, COO
Provectus Pharmaceuticals, Inc.
7327 Oak Ridge Highway
Knoxville, TN 37931 USA
O: 866.594.5999 ext. 30
M: 865.235.5485
F: 866.998.0005
[email protected]; http://www.pvct.com
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- February 7, 2014 at 5:29 pm
http://www.pvct.com/inthenews.html
04 Oct 2013
Injecting cutaneous lesions in Stage III-IV melanoma patients refractory to other treatments with PV-10 provides a viable strategy for maintaining long-term locoregional control, concluded the final analysis of an open label phase 2 trial presented as an abstract at the 2013 European Cancer Congress, 27 September to 1 October, Amsterdam.
Furthermore, the study showed that the number of lesions injected and presence of blistering were both prognostic for outcome.
Provectus Pharmaceuticals, Inc, (Knoxville, Tennessee, USA), the company behind PV-10 development, believes they now have sufficient information to seek regulatory approval.Sanjiv Agarwala, Principal Investigator of the study, said, “The take home message is that if you have injectable tumours and inject them with PV-10 there’s a one in two chance that you will achieve a clinical response, and for those patients an additional one in two chance of a non injected lesion responding.”
This, he added was remarkable in a population of patients who were refractory to a median of six previous interventions, over half of whom were aged over 70 years.
PV-10, a 10% solution of Rose Bengal, has been developed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing the potential for systemic side effects.
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- February 7, 2014 at 5:29 pm
http://www.pvct.com/inthenews.html
04 Oct 2013
Injecting cutaneous lesions in Stage III-IV melanoma patients refractory to other treatments with PV-10 provides a viable strategy for maintaining long-term locoregional control, concluded the final analysis of an open label phase 2 trial presented as an abstract at the 2013 European Cancer Congress, 27 September to 1 October, Amsterdam.
Furthermore, the study showed that the number of lesions injected and presence of blistering were both prognostic for outcome.
Provectus Pharmaceuticals, Inc, (Knoxville, Tennessee, USA), the company behind PV-10 development, believes they now have sufficient information to seek regulatory approval.Sanjiv Agarwala, Principal Investigator of the study, said, “The take home message is that if you have injectable tumours and inject them with PV-10 there’s a one in two chance that you will achieve a clinical response, and for those patients an additional one in two chance of a non injected lesion responding.”
This, he added was remarkable in a population of patients who were refractory to a median of six previous interventions, over half of whom were aged over 70 years.
PV-10, a 10% solution of Rose Bengal, has been developed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing the potential for systemic side effects.
-
- February 7, 2014 at 5:29 pm
http://www.pvct.com/inthenews.html
04 Oct 2013
Injecting cutaneous lesions in Stage III-IV melanoma patients refractory to other treatments with PV-10 provides a viable strategy for maintaining long-term locoregional control, concluded the final analysis of an open label phase 2 trial presented as an abstract at the 2013 European Cancer Congress, 27 September to 1 October, Amsterdam.
Furthermore, the study showed that the number of lesions injected and presence of blistering were both prognostic for outcome.
Provectus Pharmaceuticals, Inc, (Knoxville, Tennessee, USA), the company behind PV-10 development, believes they now have sufficient information to seek regulatory approval.Sanjiv Agarwala, Principal Investigator of the study, said, “The take home message is that if you have injectable tumours and inject them with PV-10 there’s a one in two chance that you will achieve a clinical response, and for those patients an additional one in two chance of a non injected lesion responding.”
This, he added was remarkable in a population of patients who were refractory to a median of six previous interventions, over half of whom were aged over 70 years.
PV-10, a 10% solution of Rose Bengal, has been developed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing the potential for systemic side effects.
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- December 6, 2010 at 2:05 pm
Hello Lynn.
I checked with Provectus Pharmaceuticals and asked them if patients with auto immune diseases…like rheumatoid arthritus could qualify for their PV-10 Phase 3 Trial or their Compassionate Use Program and this is the answer I received. I hope this helps. Have a great day!
Dennis, I’ve checked with Eric Wachter who runs our clinical trial programs. He says “This is not a current exclusion criterion.” So, the answer to your question is “yes.”
Please let me know of anything else.
Thanks!
Pete
Peter R. Culpepper, CFO, COO
Provectus Pharmaceuticals, Inc.
7327 Oak Ridge Highway
Knoxville, TN 37931 USA
O: 866.594.5999 ext. 30
M: 865.235.5485
F: 866.998.0005
[email protected]; http://www.pvct.com
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- December 2, 2010 at 6:59 am
I would like to know if this and what treatments are available for people with auto immune disease…like rheumatoid arthritus. I never realized how many people with melanoma stage 4 cannot take Ipi or PLX 4032 or any of the other "promising" treatments because of their disease and are reduced to using only conventional chemotherapy….I am blessed to not have any autoimmune diseases…but many of my friends do…anyone know anything "new" out there for them?
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